phase ii randomized trial of slog vs gc in locally advanced or metastatic biliary tract cancer

Conditions: Biliary Tract Neoplasms

Summary: to evaluate the following items in patients with locally advanced and metastatic biliary tract cancer receiving slog or gc treatment, primary objective: 6-month progression-free survival rate secondary objectives: objective response rate disease control rate (objective response rate (orr) + stable disease ≧ 12 weeks) progression-free survival overall survival safety profile biomarker study

to evaluate the following items in patients with locally advanced and metastatic biliary tract cancer receiving slog or gc treatment, primary objective: 6-month progression-free survival rate secondary objectives: objective response rate、disease control rate (objective response rate (orr) + stable disease ≧ 12 weeks)、progression-free survival 、overall survival 、 safety profile、biomarker study this is a randomized, open-labeled, two-arm, multi-center, phase ii clinical study. arm 1: slog regimen: every 14 days as one cycle s-1 35 mg/m2/b.i.d., day 1 - 7 (maximum dose: 120 mg/day) leucovorin 30 mg/b.i.d., day 1-7; oxaliplatin 85 mg/m2 in 250 ml of 5% glucose, given as 2-hour intra- venous infusion, day 1; gemcitabine 800 mg/m2 in 250 ml of normal saline, given as fixed dose-rate (fdr, 10 mg/m2/min) infusion, day 1; after the administration of gemcitabine, the infusion line should be flushed with 20 ml of normal saline and then 50 ml of 5% glucose solution before the administration of oxaliplatin. arm2: gc regimen: every 21 days as one cycle gemcitabine 1000 mg/m2 in 100 ml of normal saline, iv drip for 30 mins on d1 and d8 cisplatin 25 mg/m2 in 250ml of normal saline, iv drip for 2 hours on d1 and d8 treatment will be stopped in case of progressive disease, unacceptable toxicity, patients' refusal or death.

Eligibility criteria:
inclusion criteria: * patients must have histologically confirmed, advanced or metastatic biliary tract carcinoma (including intrahepatic bile duct, hilum bile duct, extrahepatic bile duct and gallbladder), except ampulla vater cancer or combined hepatocholangiocarcinoma. * presence of at least one measurable tumor lesion which is defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (ld) ≥20 mm using conventional techniques or ≥10 mm with spiral ct and mri; measurable lymph nodes must be≥15 mm in the short axis. * patients must have no history of prior chemotherapy for biliary tract cancer, except those delivered as adjuvant setting that completed at least 6 months before documentation of recurrence by imaging study. * patients with prior radiotherapy are eligible if the irradiated area does not involve the only source of measurable / evaluable disease. * patients' baseline eastern cooperative oncology group (ecog)performance status must be less than or equal 1. * patients' life expectancy must be 12 weeks or greater. * patients' age must be more than or equal 20 years old. * patients must have adequate bone marrow function, defined as white blood cell (wbc) count ≥3,500/ul, absolute neutrophil count (anc) 1,500/ul, and platelet count ≥100,000/ul. * patients must have adequate liver function and adequate renal function, defined as the following: serum alanine (alt) 3 times upper normal limit, serum total bilirubin level less than or equal 2.0 mg/dl, and creatinine clearance rate (ccr) ≥ 60 ml/min ((based upon 24-hour urine collection or calculated by cockcroft-gault formula). * patients with biliary obstruction and adequate drainage procedures before enrollment are eligible. * patients must agree to have indwelling venous catheter implanted. * women or men of reproductive potential should agree to use an effective contraceptive method. * all patients must be informed of the investigational nature of this study and must sign and give written informed consent. exclusion criteria: * patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. patients who have palliative radiotherapy for bony metastasis will be eligible 2 weeks after the completion of radiotherapy. * patients with central nervous system metastasis * patients with active infection * pregnant or breast-nursing women * patients with active cardiopulmonary disease or history of ischemic heart disease * patients who have peripheral neuropathy \> grade i of any etiology, presence of grade 2 or above ascites or pleural effusion, or ≥ grade 2 of diarrhea. * patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator. * patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin, or any malignancy remains disease-free for 3 or more years after initial curative treatment * patients who are under biologic treatment for their malignancy

Keywords: slog